BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASAHI FIELDER XT PTCA GUIDE WIRE

    MDR report key: 3551783 · Received January 3, 2014

    Report

    Report Number
    3003775027-2014-00007
    Event Type
    Injury
    Date Received
    January 3, 2014
    Date of Event
    January 1, 2006
    Report Date
    December 5, 2013
    Manufacturer
    AV-ASAHI
    Product Code
    DQX
    PMA / PMN Number
    K072431
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. FROM THE PROVIDED INFORMATION, THE RELATION BETWEEN THE GUIDE WIRE(S) AND THE EVENTS REPORTED IN THE INCIDENT REPORT COULD NOT BE IDENTIFIED. SINCE THE PRODUCTS ARE ALL INSPECTED DURING THE PRODUCTION PROCESS FOR MEETING THE SPECIFICATIONS AND SHIPPING CRITERIA, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4):DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION.A TOTAL OF 124 LESIONS EXPERIENCED PERCUTANEOUS CORONARY INTERVENTION (PCI) SUCCESS, DEFINED AS SUCCESSFUL IMPLANTATION OF AN UNSPECIFIED STENT WITH VISUAL RESIDUAL STENOSIS GREATER THAN 20% AND TIMI FLOW GRADE 3. NO ADDITIONAL INFORMATION WAS NOTED.THE ADDITIONAL HI-TORQUE INTERMEDIATE GUIDE WIRES, MIRACLE 3, MIRACLE 6, AND CONFIANZA PRO GUIDE WIRES MENTIONED ARE BEING FILED UNDER SEPARATE MANUFACTURER REPORT NUMBERS.THE CUSTOMER REPORTED THE GUIDE WIRE WAS DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.THE DEVICE IS MANUFACTURED BY ASAHI INTECC. CO. LTD. MEDICAL DIVISION; HOWEVER, (B)(4) DISTRIBUTES THE DEVICE AND IS RESPONSIBLE FOR MDR REPORTING.(B)(4). ARTICLE; FRANCESCO BURZOTTA, CARLO TRANI, ANTONELLA TOMMASINO, MARTA FRANCESCA BRANCATI, SILVIA SAFFIOTI, GIANCARLO PIROZZOLO, GIAMPAOLO NICCOLI, ANTONIO MARIA LEONE, GIOVANNI SCHIAVONI, FILIPPO CREA. (CARDIOLOGY JOURNAL 2013; VOL. 20, NO. 5, PP. 560-567): IMPACT OF OPERATOR EXPERIENCE AND WIRING TECHNIQUE ON PROCEDURAL EFFICACY OF TRANS-RADIAL PERCUTANEOUS CHRONIC TOTAL OCCLUSION RECANALIZATION PERFORMED BY DEDICATED RADIALISTS.

    Description of Event or Problem · 1

    THIS EVENT WAS CAPTURED BASED ON LITERATURE REVIEW. IT WAS REPORTED THAT FROM JANUARY 2006 TO MAY 2011, A STUDY IDENTIFIED A TOTAL OF 158 CONSECUTIVE PATIENTS WITH CHRONIC TOTAL OCCLUSIONS LOCATED IN A MAJORITY (70) LEFT ANTERIOR DESCENDING CORONARY ARTERIES, WITH TIMI FLOW 0 IN 167 UNSPECIFIED CORONARY ARTERIES, WHO WERE TREATED VIA RADIAL ACCESS USING ONE OR MORE ABBOTT HI-TORQUE INTERMEDIATE GUIDE WIRES AND/OR THE FOLLOWING ASAHI GUIDE WIRES IN EACH PATIENT: MIRACLE 3, MIRACLE 6, CONFIANZA PRO, AND FIELDER XT. OF THE 158 PATIENTS, CLINICAL OUTCOMES WERE AS FOLLOWS: TARGET VESSEL REVASCULARIZATION: 7; RE-PERCUATANEOUS CORONARY INTERVENTION: 4; CORONARY ARTERY BYPASS GRAFT: 3; MINOR GUIDE WIRE-INDUCED PERFORATION SEALED BY ANTI-COAGULATION REVERSAL AND PROLONGED BALLOON INFLATION: 1; A MINOR ACCESS-SITE FOREARM HEMATOMA WHICH WAS SUCCESSFULLY TREATED BY PROLONGED COMPRESSIVE BANDAGE: 1; POTENTIAL RADIAL ARTERY SPASM: NUMBER UNSPECIFIED; POTENTIAL VASCULAR (ENDOTHELIAL) DAMAGE: UNSPECIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3606 ASAHI FIELDER XT PTCA GUIDE WIRE GUIDE WIRE DQX AV-ASAHI

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R| S